Assessment of the SYNOVIUM HCS Device for knee osteoarthritis
Official title: Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Run by LCA Pharmaceutical · NCT06087705 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new device for knee osteoarthritis to see if it helps reduce pain and improve movement after receiving a hyaluronic acid injection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | LCA Pharmaceutical Industry-sponsored |
| Locations | 1 site (Saint-Brieuc) |
| Trial ID | NCT06087705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with radiologically confirmed gonarthrosis and moderate walking pain who are scheduled to receive a SYNOVIUM HCS injection.
✕Probably not a fit
Patients with recent viscosupplementation or corticosteroid injections, inflammatory arthritis, or those with certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the safety and performance of the SYNOVIUM HCS device in patients with gonarthrosis. Participants will receive an intra-articular injection of hyaluronic acid and will be monitored over a 6-month follow-up period. Data on pain and disability will be collected before and after the injection to assess the device's effectiveness. The study aims to gather real-life data to better understand the outcomes associated with this treatment.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of SYNOVIUM HCS for alleviating knee pain in osteoarthritis patients.
How similar studies have gone: Other studies have shown positive outcomes with hyaluronic acid injections for knee osteoarthritis, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient * Patient with radiologically characterized gonarthrosis (stages Kellgren \& Lawrence grades I to III) * Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4 * Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment * Patient agreeing to participate in the study * Patient affiliated to a social security scheme or benefiting from such a scheme Exclusion Criteria: * Viscosupplementation less than 6 months old * Intra-articular corticosteroid injection less than 2 months old * Inflammatory arthritis or active infectious of the knee studied * History of surgery of the lower limb concerned * Kellgren \& Lawrence grades not defined * Known hypersensitivity to hyaluronic acid or chondroitin sulfate * Pregnant or breastfeeding women * Patient under guardianship, curatorship or judicial safeguard * Patient participating in another clinical investigation, at the time of inclusion
Where it's running
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CRRF en Milieu Marin de Trestel
Saint-Brieuc, France Recruiting
Study contacts
- Principal investigator: Dominique BARON — CRRF en Milieu Marin de Trestel
- Study coordinator: Patrice VINCENT
- Email: pvin@lca-pharma.com
- Phone: 02 37 33 39 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.